Dual Therapy Can Reduce TB Prophylaxis From Nine Months to One: Fewer Side Effects and More People Complete Treatment

New results from a large international study using a simplified approach to prevent TB have the potential to dramatically improve outcomes for HIV positive people, cutting prophylaxis from nine months to one.

The BRIEF-TB study randomised 3000 adults with either latent TB or at high risk of TB infection to either one month of daily isoniazid (H) 300 mg plus rifapentine (P) 450-600 mg or to the standard of care nine-month regimen with daily isoniazid 300 mg.

The study included three years follow-up with primary endpoints of incidence rates (IR) of active TB, TB death or death by unknown cause, and stratified participants by ART use.

This was a non-inferiority study with lower margin of 1.25/100 patient years, based on an assumed IR of 2.0/100 PY in the nine-month arm. Results were presented by Richard Chaisson from Johns Hopkins University.

The study recruited participants from May 2012 to November 2011 in 45 sites in 10 countries.

Baseline demographics included 54% women (n=1614), median age 35 years (IQR 28-43), with 66% black and 24% Hispanic. Median CD4 count was 470 cells/mm3 (IQR 346 to 635) and 50% were on ART at entry. Median BMI was 23.5 (IQR 20.9 to 27.1). Approximately 20% (n=634) had latent TB defined by positive TST or IGRA.

After three years of follow-up, there were no significant difference in the rate of primary events: in 34 vs 35 participants in the one vs nine month arms respectively. TB incidence rates were 0.69 vs 0.72/100 person years respectively (difference -0.025, upper 95% CI: 0.31).

Rates were higher for participants not on ART at entry and those with a positive TST/IGRA, but with no difference between treatment arms. Higher incidence in the one-month arm with baseline CD4 count <250 cells/mm3 was not statistically significant (p=0.12). See Table 1.

This article was provided by HIV i-Base. It is a part of the publication The 25th Conference on Retroviruses and Opportunistic Infections. Visit HIV i-Base's website to find out more about their activities, publications and services.

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